Erchonia® Cellulite Removal Machines: Save on Staff Costs, Expand Treatment Range, Get the Best Results

All studies carried out to obtain FDA-clearance are double blind, randomised, placebo-controlled, and multi-site – the most credible research in the market.

The following list shows the clinical trials and an outline of their progress. As a company, to protect our intellectual assets, not all clinical trials we are involved with are made public so as to maintain our competitive advantage. As such, not all clinical trials are listed below.

Please note: There are hundreds of clinical studies confirming the effectiveness of Low-Level Laser Therapy (LLLT), and every year there are many new publications. Below is a list of Erchonia-specific studies for FDA-clearance.

1) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference in Individuals With a Body Mass Index (BMI) of up to 40 kg / m² – 2019 – The data used to get this approval combined all previous data Erchonia® had on 20-40 BMI patients in the green laser studies below.

2) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Body Circumference — 2016.
FDA-clearance – K162578

3) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist, Thighs and Upper Abdomen — 6 Week Treatment Protocol — 2014 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K150446
To view NIH clinical trial records, click here.

4) Non-Invasive Dermatological Aesthetic Treatment for the Reduction of Circumference of Hips, Waist and Thighs — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K143007
To view NIH clinical trial records, click here.

5) Non-Invasive Dermatological Aesthetic Treatment for Reduction of Circumference of Hips, Waist and Upper Abdomen When Applied to Individuals with a Body Mass Index (BMI) Between 30 kg/m2 and 40 kg/m2 — 2013 – Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K142042
To view NIH clinical trial records, click here.

6) Non-Invasive Body Contouring Using GLS Laser – 532 nm (Green) Trade Name Verju — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K123237
To view NIH clinical trial records, click here.

7) Appearance of Cellulite (Verju Laser System) — 2012 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
FDA-clearance – K130922
To view NIH clinical trial records, click here.

8) Arm Circumference Reduction of the Upper Arms — 2011 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
Study results used to obtain FDA-clearance – K120257
To view NIH clinical trial records, click here.

9) Non-Invasive Fat Reduction and Body Contouring – Laser Scanner Waist, Hips, and Thighs — 2009 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
Study results used to obtain FDA-clearance – K082609
To view NIH clinical trial records, click here.

10) Low-Level Laser Light Therapy as an Aid to Liposuction and Reduction of Pain Associated With Surgery — 2004 — Sponsor and monitor, IRB approved, double blind, placebo controlled, multi-site, clinical study.
Study results used to obtain FDA-clearance – K041139
To view NIH clinical trial records, click here.

While the benefits of Low-Level Laser Therapy (LLLT) have been observed in hundreds of medical studies, the exact mechanisms that lead to these results are still being explored. Although we still have a lot to learn about the effects of light energy on different types of cells, the leading theory is that LLLT helps to remove fat by creating transient pores in adipocytes, allowing lipids to leak out.

That is, Erchonia® lasers create a small transitory pore for the fatty liquids in fat cells to seep out. The fatty liquids are then naturally flushed out through the lymphatic system.

The result is that the fat cells shrink instead of being killed. When this happens, the shrunken fat cells begin to act and function like healthy lean cells, releasing the correct messages to the brain and creating a communication effect throughout the fat organ, causing other fat cells to release their content and return their hormone responses to the positive.

Procedures that have been popular in the past (such as fat freezing) focus on the elimination of fat cells, but recent research has shown this approach to be less effective, and in the worst-case scenario, providing counterproductive results.

Erchonia® lasers effectively train fat cells to behave and react differently, and all without excessive heat or cooling.

Erchonia® fat & cellulite removal machines have been scientifically proven to be the most effective fat loss devices on the market today. The lasers are completely pain free, have been clinically proven to be safe and effective, and provide relaxing treatments with numerous health and wellness benefits for the patient (which is more important than ever in the current climate). Furthermore, there have been no reported side effects or adverse reactions with our technology, and the system is truly inspired by the simplicity of nature, differentiating us from competing products in the sector.

Erchonia® lasers can be used to treat small pockets of fat or larger surface areas, and are FDA Market Cleared for overall circumferential reduction on patients up to 40 BMI. Many competing companies advertise their products as ‘clinically proven’, guaranteeing ‘instant results’. However, these claims are often not backed by comprehensive clinical evidence.

It is also sometimes the case that competing technologies are marketed as ‘FDA-cleared’, but this clearance is quite weak or not related to fat loss. For example, perhaps the clearance is for wrinkles and rhytids, or for temporary fat reduction. We always recommend that you ask for details of the FDA-clearances and make an informed decision – pay particular attention to the scope of the clearance, how many patients participated, whether it was placebo controlled, double blind, and randomised, how many peer reviewed published articles they have, and what the adverse reactions / side effects were (we would be happy to provide this information for you).

Statements From the FDA

• Emerald – 6 inches / 15.24 cm average reduction in waist, hips, and upper abdomen (51.33 mm off waist) – 1 month.
• Verjú (Emerald Predecessor) – 11.48 cm reduction in waist, hips, and thighs – 2 weeks.
• BTL Emsculpt Neo – 3.2 ± 1.64 cm change in abdominal circumference – 3-month follow-up. Note: Unreliable findings – not double blind, placebo controlled, or randomised.
• CoolSculpting / Zeltiq – No reduction. Appearance claim only (1.78 – 2.66 mm at 4 months).
• Liposonix (Ultrasound) – 1 inch loss at 4 months.
• Ultrashape (Ultrasound) – 1 inch loss at 4 months.
• Sculpsure (Thermal Laser) – 1.785 mm at 12 weeks.

To understand the properties of non-thermal lasers, it is first important to distinguish between High-Level Laser Therapy (HLLT) and Low-Level Laser Therapy (LLLT):

• HLLT devices are classified as ‘Class IV Lasers’ by the FDA in virtue of having a power output that’s greater than 500mW (i.e. high risk of hazard).
• LLLT devices are classified as either ‘Class IIIB Lasers’, ‘Class IIIR Lasers’, or ‘Class II Lasers’ in virtue of having a power output of 5-500mW, 1-5mW, or <1mW respectively (i.e. lower risk of hazard).

The vast majority of HLLT devices have longer near-infrared (NIR) wavelengths – there is a common misconception, often propagated by the manufacturers of such devices, that high power with longer wavelengths results in:

1. Deeper penetration, allowing for the treatment of a wider range of conditions.
2. More efficacious results (due to the delivery of more energy into the cells).

This however, is not correct for the following well-documented reasons:

1. Due to the high absorption rate of laser light by water at wavelengths greater than 950nm, most of the energy produced at this wavelength (or above) is absorbed before penetrating the dermis.
2. The key principle behind Laser Therapy is to generate therapeutic effects by stimulating and enhancing specific biochemical processes within cells. More specifically, utilising the first law in photochemistry (Grotthuss-Draper law), laser energy is transferred to cytochrome c oxidase (CcO) – a respiratory energy-transducing enzyme which is involved in the electron transport chain in mitochondria. This energy transfer causes photodissociation of inhibitory nitric oxide from CcO, leading to an enhancement of enzyme activity, electron transport, mitochondrial respiration, and adenosine triphosphate (ATP) production. Consequently, by altering the cellular redox state, Laser Therapy induces the activation of numerous intracellular signalling pathways, and alters the affinity of transcription factors concerned with cell proliferation, survival, repair, and regeneration. However, there is an optimal ‘dose’ of laser energy (typically 2-4 joules / cm²) required for stimulating and enhancing these desired biochemical processes – HLLT devices exceed this optimal level.

Put simply, HLLT devices deliver too much energy at inefficient wavelengths, resulting in a lack of efficacy and increased costs.

To add to this, the high outputs used by such devices produce painful heat sensations, further limiting their scope of treatment.

In essence, HLLT devices should only be used for laser surgery and tissue ablation – the high outputs are effective for cell destruction, but are not suited for therapeutic purposes, contrary to the claims of Class IV manufacturers.

LLLT devices, on the other hand, aim to deliver energy via low output, short wavelength beams of light. The general theory is that this approach transfers the optimal amount of energy for stimulating and enhancing cell function, while not damaging cells or producing painful heat sensations.

Within the LLLT sector however, some of the higher-output devices still generate heat / pain. Furthermore, many devices are advertised as ‘lasers’, when in fact they are Light Emitting Diodes (LEDs) or Superluminescent Diodes (SLDs). In contrast to LEDs or SLDs, ‘true’ lasers generate monochromatic, collimated, and coherent beams of light. That is, the light emitted by a true laser is composed from photons that have the same wavelength (monochromatic), travel in the same direction / do not disperse (collimated), and are in phase in space and time (coherent). These three properties of true lasers make them the most effective and efficient LLLT devices.

To separate Erchonia® from such technologies, and from HLLT more generally, we say that our lasers are ‘non-thermal, true lasers’. That is, Erchonia® lasers do not produce any heat or painful sensations, and are monochromatic, collimated, and coherent.

There are two basic steps when administering Erchonia® treatments. First, we find the most severe areas of subcutaneous fat or cellulite. Then, we use the diodes to target this area, positioning them around 9 – 15 cm away from the skin. This optimises exposure to the generated beams, and treats the target area whilst the client relaxes.

There are no code regulated contraindications, however, since there are no long-term evaluations on certain conditions, we do not recommend using Erchonia® lasers on pregnant women, clients with a pacemaker, or clients with photosensitive epilepsy. We also do not recommend using the devices over an area of known cancer.

The treatments are officially labelled as ‘non-temporary’ by the FDA, so as long as your clients lead a normal to healthy lifestyle, their results will continue. To give an example, if your clients consume 4000 calories per day, although they will lose inches during the Erchonia® treatments, they may quickly put these inches back on.

We generally recommend that you promote small lifestyle changes along with the Erchonia® course, with the option of maintenance treatments if required.

Erchonia® treatments are just 30 minutes long and fully automated, allowing you to save on staff costs and increase profits.

Your clients should see improvements after the very first session, and the results will continue to improve with each treatment.

However, the number of treatments that your clients will require depends on their aims, objectives, lifestyle, medical history, and any medication that they may be on – in general, most patients will need 6+ sessions, with one, two, or three treatments per week.

Erchonia® fat & cellulite removal machines treat overall body circumference while also allowing your clients to target stubborn areas of fat and cellulite.

Most people who undergo the treatments focus on their midriff and thighs, but the device can also target any area of subcutaneous fat, including bra strap, upper arms, jowls, knees, and more.

Please examine the image below for the possible treatment options:

Erchonia® lasers are used in many areas, such as 360-degree fat loss, body sculpting, cellulite reduction, pain management, pre / postsurgical healing, pre / rehabilitation, nail and skin pathologies (e.g. nail fungus and acne), and more.

Not only do our lasers treat specifics, but they also empower the body to function efficiently due to the beneficial effects they have on our cells.

Erchonia® technologies do not have any downtime or associated pain, and there are no recorded side effects or adverse reactions – Erchonia® lasers inspire our bodies to act to produce ‘a better you’.